In these Regulations —

• “the Act” means the Food Safety Act 1990;

• “Directive 84/500/EEC” means Council Directive 84/500/EEC on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs M1;

• “Directive 2007/42/EC” means Commission Directive 2007/42/EC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs M2;

• “Regulation 1935/2004” means Regulation (EC) No. 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EECM3;

• “Regulation 1895/2005” means Commission Regulation (EC) No. 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food M4;

• “Regulation 2023/2006” means Commission Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food M5;

• “Regulation 450/2009” means Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food M6;

• “Regulation 10/2011” means Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food M7;

• “authorised officer” means any person, whether or not an officer of the authority concerned, who is authorised in writing by an authority having responsibility for execution and enforcement under regulation 20 to act in matters arising under these Regulations;

• “food authority” does not include the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple) nor a port health authority;

• “port health authority” means —

  1. a

     in relation to the London port health district (within the meaning given to that phrase for the purposes of the Public Health (Control of Disease) Act 1984 M8 by section 7(1) of that Act), the Common Council of the City of London; and

  2. b

     in relation to any port health district constituted by order under section 2(3) of the Public Health (Control of Disease) Act 1984, a port health authority for that district constituted by order under section 2(4) of that Act;

• “preparation” includes manufacture and any form of treatment or process, and “prepare” is to be construed accordingly.

Expressions used in these Regulations and in Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 or Regulation 10/2011 bear the same meaning in these Regulations as they bear in those Regulations.

Any reference in these Regulations to Regulation 2023/2006 or to any Annex to Directive 2007/42/EC or Regulation 10/2011 is a reference to that Regulation or that Annex as amended from time to time.

No person may place on the market or use, in the course of a business in connection with the storage, preparation, packaging, sale or service of food any material or article that does not comply with the requirements of Article 3(1) (general requirements) or Article 4(1),(2),(3) or (4) (special requirements for active and intelligent materials and articles).

No person may place on the market any material or article that does not comply with the requirements of Article 3(2), 4(5) or (6) or 15(1),(3),(4),(7) or (8) as read with Article 15(2) (labelling).

Any person who contravenes paragraph (1) or (2) or Article 11(4) or (5) (Community authorisation) or 17(2) (traceability) is guilty of an offence.

In this regulation a reference to a numbered Article is a reference to that Article in Regulation 1935/2004.

The competent authority for the purposes of Article 6(2) (quality control system) and 7(3) (documentation) of Regulation 2023/2006 is each food authority in its area.

Subject to the transitional provisions contained in Article 14 (entry into force and application) of Regulation 450/2009, any person who places on the market any active or intelligent material or article which does not comply with the requirements of Article 4 of that Regulation is guilty of an offence M9.

Any person who fails to comply with the requirements of Article 13 (supporting documentation) of Regulation 450/2009 is guilty of an offence.

The quantities of lead or cadmium transferred from a ceramic article must not exceed the limits laid down in Article 2(4) as read with Article 2(3) and (5).

Unless it is demonstrated that the materials used to make the ceramic article did not contain lead or cadmium, compliance with paragraph (1) is to be determined by testing and analysis in accordance with Annexes I and II.

No person may place on the market a ceramic article that does not comply with the requirements of paragraph (1) as read with paragraph (2).

A person who places on the market a ceramic article that is not yet in contact with food must provide a written declaration complying with paragraph (5) to accompany the article at the marketing stages up to and including the retail stage.

The declaration must be issued by the manufacturer or by a person established within the EU who placed the ceramic article on the market and must contain the information laid down in Annex III.

Paragraphs (4),(5) and (6) do not apply in relation to a ceramic article which is second-hand.

The documentation specified in paragraph 6(a),(b) and (c) is not required where documentary evidence is provided to show that the materials used to make the ceramic article did not contain lead or cadmium.

Except in regulation 12(3), any reference in this Part to a numbered Annex is a reference to that Annex to Directive 2007/42/EC.

PRCF may be manufactured, prior to coating, using only substances or groups of substances listed in the first part of Annex II and subject to the restrictions set out in that part.

The coating to be applied to PRCF may be manufactured using only substances or groups of substances listed in Annex I to Regulation 10/2011 and subject to the restrictions in that Annex.

Materials and articles made of PRCF must comply with Article 12 (overall migration limit) as read with Article 17 (expression of migration test results) and Article 18 (rules for assessing compliance with migration limits) of Regulation 10/2011.

Printed surfaces of regenerated cellulose film must not come into contact with foodstuffs.

Any material or article made of regenerated cellulose film that is not by its nature clearly intended to come into contact with food must, at a marketing stage other than the retail stage, be accompanied by a written declaration attesting that it complies with the legislation applicable to it.

Where special conditions of use are indicated, the material or article made of regenerated cellulose film must be labelled accordingly.

No person may place on the market any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (1) to (4), or which fails to comply with paragraphs (5),(6) or (7).

Subject to the transitional arrangements set out in Article 22(4) and (5) and Article 23 M10, any person who places on the market a plastic material or article that fails to comply with a requirement of Regulation 10/2011 specified in column 1 of the Schedule is guilty of an offence.

Any person who fails to comply with the second sentence of Article 8 (general requirements on substances) or, subject to transitional arrangements set out in Article 22(1),(2) and (3) M11, with Article 16 (supporting documents) is guilty of an offence.

Subject to Article 6(3) M14, no person may place on the market any material or article which fails to comply with the requirements of Article 5 (written declaration) M15.

Any person who contravenes paragraph (2) or (3) is guilty of an offence.

Any person who contravenes the provisions of regulation 10(3) or (4), 12(8) or 18(2) is guilty of an offence.

Any person who intentionally obstructs any person acting in the execution of Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009, Regulation 10/2011 or these Regulations is guilty of an offence.

Any person who, without reasonable excuse, fails to provide any assistance or information that person may reasonably require for the performance of their functions under the Regulations mentioned in paragraph (2) or fails to comply with regulation 10(6) is guilty of an offence.

Any person who, in purported compliance with any requirement mentioned in paragraph (3), knowingly or recklessly supplies information that is false or misleading in any material particular, is guilty of an offence.

Nothing in paragraph (2) or (3) is to be construed as requiring any person to answer any question or give any information if to do so might incriminate them.

Each food authority in its area shall execute and enforce the provisions of Regulation 2023/2006 specified in regulation 5 and these Regulations.

Where an offence under these Regulations which has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of a partner, that partner as well as the partnership shall be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.

No prosecution for an offence under these Regulations shall be begun after the expiry of three years from the commission of the offence or one year from its discovery by the prosecutor, whichever is the earlier.

Paragraph (1) does not apply to an offence under regulation 7(2), 14(2) or 19(2) or (3).

In any proceedings for an offence under these Regulations it shall, subject to paragraph (5), be a defence to prove that the person accused (“the accused”) took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by the accused or by a person under the control of the accused.

Without prejudice to the generality of paragraph (1), a person accused of an offence under regulation 4(3), 7(1), 14(1), 16(4) or 19(1) who did not import or prepare the material or article in respect of which the offence is alleged to have been committed shall be taken to have established the defence provided by paragraph (1) if the requirements of paragraphs (3) or (4) are satisfied.

An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed shall divide the sample into three parts.

If the sample consists of sealed containers and opening them would, in the opinion of the authorised officer, impede a proper analysis, the authorised officer shall divide the sample into parts by putting the containers into three lots, and each lot shall be treated as being a part.

The Government Chemist shall analyse the part sent under paragraph (2) and send to the authorised officer a certificate specifying the results of the analysis.

Any certificate of the results of analysis transmitted by the Government Chemist shall be signed by or on behalf of the Government Chemist, but the analysis may be carried out by any person under the direction of the person who signs the certificate.

The authorised officer shall immediately on receipt supply the prosecutor (if a person other than the authorised officer) and the accused with a copy of the Government Chemist's certificate of analysis.

Where a request is made under paragraph (2)(b)(iii) the authorised officer may give notice in writing to the accused requesting payment of a fee specified in the notice to defray some or all of the Government Chemist's charges for performing the functions under paragraph (3), and in the absence of agreement by the accused to pay the fee specified in the notice the authorised officer may refuse to comply with the request.

In this regulation “the accused” includes a person against whom an authorised officer is intending to commence proceedings.

In the application of section 32 of the Act (powers of entry) for the purposes of these Regulations, the reference to the Act in subsection (1) is to be construed as including a reference to Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 or Regulation 10/2011 as appropriate.

The Food Labelling Regulations 1996 M20 are amended in accordance with paragraph (2).

In regulation 2(1) (interpretation), for the definition of “ingredient” substitute the following definition —

Paragraphs (1) and (2) expire on 13th December 2014.

In carrying out the review the Food Standards Agency must, so far as is reasonable, have regard to how the EU instruments are implemented or executed and enforced in other Member States.

The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

Reports under this regulation are afterwards to be published at intervals not exceeding five years.

In this regulation “the EU instruments” means Council Directive 78/142/EEC on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs M21, Directive 84/500/EEC, Directive 2007/42/EC, Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 and Regulation 10/2011.